This article is more than 5 years old. Information may no longer be current.
FDA approves once-daily ADHD treatment for children aged 6 to 17 years
Click Here to Manage Email Alerts
The FDA has approved guanfacine extended release tablets (Intuniv, Shire) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years.
Once-daily guanfacine extended release tablet is expected to be available next month and will come in four dosage strengths (1 mg, 2 mg, 3 mg and 4 mg).
“Everyday situations and challenges may be difficult for children and adolescents with ADHD as it is a disruptive disorder that includes symptoms and behaviors such as being easily distracted, always on the go, interrupting others, arguing with adults or temper outbursts,” Frank A. López, MD, a neurodevelopmental pediatrician in private practice at Children’s Developmental Center in Winter Park, Fla., said in a press release. “In clinical trials, Intuniv, a selective alpha-2A receptor agonist, significantly reduced ADHD symptoms across a full day as measured by parents.”
Clinical trials
The efficacy of this medication was established in two similarly designed, placebo-controlled clinical trials in children and adolescents aged 6 to 17 years who met diagnostic criteria for ADHD. Statistically significant improvements were reported by investigators, parents and teachers.
The first trial was a phase 3, double-blind, parallel-group trial, in which investigators randomly assigned 345 children aged 6 to 17 years to either a placebo or a fixed 2-mg, 3-mg, or 4-mg dose of Intuniv given once daily during an eight-week period. The second trial was a phase 3, double-blind, parallel-group trial, in which researchers randomly assigned 324 children aged 6 to 17 years to either a placebo or a fixed 1-mg, 2-mg, 3-mg, or 4-mg dose of Intuniv given once daily during a nine-week period, with the 1 mg assigned only to patients weighing less than 50 kg (110 lbs).
In both trials, doses were increased in increments of 1 mg per week, and investigators evaluated participants’ signs and symptoms of ADHD on a once-weekly basis using the clinician administered and scored ADHD Rating Scale-IV (ADHD-RS-IV). The primary outcome was the change in total ADHD-RS-IV scores from baseline to end point in both studies.
Both trials demonstrated statistically significant improvements in ADHD-RS-IV scores in patients taking the medication beginning one to two weeks after patients began receiving once-daily doses. In the first pivotal trial, the mean reduction in ADHD-RS-IV total scores at end point were -16.7 for Intuniv compared with -8.9 for placebo (P<.0001), the mean reduction in ADHD-RS-IV total scores in the second pivotal trial were -19.6 for Intuniv and -12.2 for placebo (P=.0040).
Additional secondary efficacy outcome measures included the Conners’ Parent Rating Scale-Revised: Short Form (CPRS-R) and the Conners’ Teacher Rating Scale-Revised: Short Form (CTRS-R), which are comprehensive scales that use parent and teacher observer and self-reported ratings to help assess ADHD and evaluate behavioral issues in children and adolescents.
Significant improvements were seen on both scales: based on the CPRS-R, parents reported significant improvement across a full day; based on the CTRS-R, which was used only in the first trial, teachers reported significant improvement throughout the school day.
Investigators also measured the efficacy of Intuniv with the Clinical Global Impressions-Improvement (CGI-I) scale, a standard assessment used to rate the improvement of a patient’s illness over the course of the study. The pivotal trial found the percentage of trial participants taking Intuniv were rated “much improved” or “very much improved” at endpoint ranged from approximately 50% to 56% across all doses compared with approximately 26% for placebo (P<.05).
Safety was also evaluated during these pivotal trials, and safety data showed that adverse events reported by participants using the study medication were generally mild to moderate in severity, with the most common side effects being sedative in nature. Small to modest changes in blood pressure, pulse rate, and ECG parameters were observed.